Effect of Probiotic Lacobacillus Reuterii on Serum Bilirubin Levels in Preterm Infants

Hasanuddin University

Status

Completed

Conditions

Hyperbilirubinemia, Neonatal

Treatments

Dietary Supplement: Lactobacillus reuterii

Study type

Interventional

Funder types

Other

Identifiers

NCT06672406

UH105201003

Details and patient eligibility

About

The goal of this clinical trial is to learn about the effect of probiotic Lactobacillus reuterii on the level of serum bilirubin in moderately and late preterm infants with birth weights 1000 grams to 2499 grams who were admitted to the NICU at Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital. The main questions it aims to answer are:

Are bilirubin levels in preterm infants who received probiotics were lower than those who did not receive probiotics?
Is the incidence of hyperbilirubinemia requiring phototherapy in preterm infants who received probiotics less than those who did not receive probiotics?

Full description

This study aims to investigate the effect of probiotic Lactobacillus reuteri administration on serum bilirubin levels in preterm infants. It is a randomized controlled trial conducted at the Neonatal Intensive Care Units of Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital in Makassar, South Sulawesi, Indonesia. The study population includes infants born at 32 to <37 weeks gestational age with birth weights between 1000-2499 grams who are admitted to the NICU. Eligible infants are randomized into two groups - an intervention group receiving probiotic L. reuteri (5 drops daily for 7 days) and a control group not receiving probiotics. The primary outcome is serum bilirubin levels, measured at baseline and after 7 days of intervention. Secondary outcomes include incidence of hyperbilirubinemia requiring phototherapy and changes in bilirubin levels in those receiving phototherapy. Blood samples are collected to measure total and direct bilirubin levels. The study aims to enroll 40 infants (20 per group) to detect a clinically meaningful difference in bilirubin levels between groups. This trial will provide evidence on whether probiotic supplementation with L. reuteri can reduce the severity of hyperbilirubinemia in preterm infants. The results may inform clinical practice regarding the use of probiotics as an adjunctive therapy for neonatal jaundice in this vulnerable population.

Enrollment

40 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

Inclusion criteria

Premature Infants (32 - < 37 weeks gestation)
Birth weight 1000 - 2499 grams
Sick infants who are treated in the NICU
Preterm infants who received enteral feeding > 30 cc/kgBB less than 72 hours after birth, without jaundice or jaundice Kremer 1,2, and 3
Parents have signed their child's consent to participate in the study

Exclusion criteria

Infants with multiple congenital abnormalities
Infants with jaundice before 24 hours or having jaundice cremer > 4 less than 72 hours from birth
Infants with Sepsis, Metabolic acidosis